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A Randomized Control Trial to Assess Early Clinical and Functional Outcome of the ROCC and LCS Total Knee Implant Designs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00755144
Recruitment Status : Completed
First Posted : September 18, 2008
Last Update Posted : June 20, 2017
Sponsor:
Collaborator:
Biomet U.K. Ltd.
Information provided by (Responsible Party):
Zimmer Biomet

Brief Summary:
This is a prospective Randomised Control Trial to compare the Early Clinical and Functional Outcome of the ROCC and LCS total knee arthroplasty implant designs.

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: LCS Knee Device: ROCC Knee Not Applicable

Detailed Description:
This study compares two similar designs of cementless rotating bearing total condylar knee replacements. The study will be conducted at a single clinical unit with a senior orthopaedic surgeon implanting all devices.Their performances will be assessed by clinical scores and comprehensive function outcome documentation undertaken by qualified physiotherapists. The persons undertaking the assessments will be blinded to which implants the patients have.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Study on Early Clinical and Functional Outcome of the ROCC and LCS Total Knee Arthroplasty Implant Designs
Study Start Date : April 2007
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
ROCC
Device: ROCC Knee
Cementless total knee arthroplasty with ROCC Knee

Active Comparator: 2
LCS
Device: LCS Knee
Cementless total knee arthroplasty with LCS Knee




Primary Outcome Measures :
  1. American Knee Society Score [ Time Frame: Preoperative, 8weeks, 1 year ]

Secondary Outcome Measures :
  1. WOMAC [ Time Frame: preoperative, 8 weeks, 1 year ]
  2. VAS Pain [ Time Frame: Preoperative, 4weeks, 8weeks, 3months, 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients suitable for cementless knee replacement
  • Patients skeletally mature and under 80 years of age at pre-operative clinic
  • Patients presenting with osteoarthritis of the knee
  • Patients must be ambulatory at time of pre-operative clinic
  • Patients must be able to understand instructions and be will to return for follow-up

Exclusion Criteria:

  • Previous knee surgery (except arthroscopic/open menisectomy)
  • Patients with inflammatory arthritis
  • Patients with significant medical co-morbidity - ASA IV
  • Disorders causing abnormal gait or significant pain
  • Patients unable to consent
  • Severe visual impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00755144


Locations
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United Kingdom
Musgrave Park Hospital
Belfast, United Kingdom
Sponsors and Collaborators
Zimmer Biomet
Biomet U.K. Ltd.
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT00755144    
Other Study ID Numbers: BMET UK 05
First Posted: September 18, 2008    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases